Aspirin, Simvastatin Provide No Benefit for PAH: Study

Taking aspirin or simvastatin does not appear to benefit those with pulmonary arterial hypertension (PAH), according to recently published research.

Researchers from the University of Pennsylvania School of Medicine conducted a study with 65 patients with PAH who had been randomized into four groups: those taking aspirin, simvastatin, aspirin plus simvastatin, or neither.

The investigators used a six-minute walk distance (6MWD) as the key outcome measure in the study, and found that the 6MWD tended to be lower among those taking simvastatin at six months.

The investigators also found no significant difference in the 6MWD between those who received aspirin and those who received placebo. The results of this study do not support the routine treatment of PAH with aspirin or simvastatin.

The research was published in Circulation, coinciding with a presentation at the American Thoracic Society’s 2011 International Conference in Denver.

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NWBT, Fraunhofer Partner to Produce DCVax

Northwest Biotherapeutics and Fraunhofer have announced that they are partnering to produce DCVax®-L for brain cancer for both clinical trials and compassionate use cases in Europe.

Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis.

Fraunhofer — a highly respected leader in many areas of technology, including cell and immune therapies — is the largest applied research foundation in Europe.  The company has a staff of more than 18,000 scientists, engineers, and business personnel dedicated to practical applications and commercialization of research results.

The Fraunhofer Institute for Cell Therapy and Immunology IZI, based in Leipzig, Germany, has dedicated a substantial portion of its state-of-the-art manufacturing facilities to the production of DCVax®, and is assisting NWBT with the applicable regulatory requirements for both clinical trials and compassionate use cases.

The partnership will enable NWBT to advance clinical trials in Europe, and to provide compassionate use treatments of patients along with clinical trials.

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Neuronetics, Inc. Completes Series E Financing for $30 Million

Neuronetics, Inc. has announced that it has completed its Series E financing totaling $30 million, with two new investors — Polaris Venture Partners and Pfizer Venture Investments — leading the round.

Neuronetics, Inc. is the maker of the NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy® System for the treatment of major depression. Investor Growth Capital, New Leaf Venture Partners, Interwest Partners, Three Arch Partners, Quaker BioVentures, and Onset Ventures are previous investors who participated in the round.

Neuronetics has marketed the NeuroStar TMS system for the treatment of major depression for patients who have not adequately benefitted from prior antidepressant medication.  The therapy system was cleared by the United States Food and Drug Administration in October 2008.

“This financing is a tremendous vote of confidence in the potential of NeuroStar TMS Therapy by two premier life science investors,” said Bruce J. Shook, President and CEO of Neuronetics, Inc. “The financial resources, experience and knowledge that Polaris and Pfizer bring to our company will allow us to build on our success and accelerate our efforts to bring NeuroStar to the millions of people suffering from depression.”

“The market opportunity for a novel, non-invasive and non-systemic treatment for major depression like Neuronetics’ NeuroStar TMS Therapy is extremely attractive,” said Kevin Bitterman, Ph.D., Principal at Polaris Venture Partners. “The NeuroStar TMS system gives psychiatrists an entirely new tool in their effort to treat those patients who are struggling with depression and do not get relief from existing therapies. The team at Neuronetics has done an impressive job of bringing this technology into mainstream medical practice, and we look forward to helping advance this important effort.”

“Pfizer has had a longstanding interest in treating depression,” said Elaine Jones of Pfizer Venture Investments. “We look at Neuronetics’ progress as the beginning of a potentially important advance in how we treat this often debilitating, chronic and costly disease. We are excited about supporting Neuronetics’ effort to bring a new and innovative solution to psychiatry.”

Neuronetics, Inc. is a privately held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic-field pulses. Based in Malvern, Penn., Neuronetics is the leader in the development of NeuroStar TMS Therapy, a non-invasive and non-systemic form of neuromodulation. Neuronetics, Inc. was represented in the Series E financing by Pepper Hamilton, LLP.

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New Research on Neurodevelopmental Outcomes of Children with CHD

Researchers from the Cardiac Center at The Children’s Hospital of Philadelphia have found that children with congenital heart defects (CHD) who receive heart surgery in infancy experience better neurodevelopmental outcomes at age four when born closer to term. Better outcomes were found in infants born after 39 weeks versus infants born at 36 to 38 weeks.

Concerns over maternal and fetal health often prompt early delivery of children with CHD. When health concerns are not present, this research suggests that elective or spontaneous delivery at 39-40 weeks is preferable as it is associated with better neurodevelopmental outcomes.

The researchers analyzed a total of 351 infants born at 36 weeks gestation or later that were enrolled in a study for apolipoprotein-E (APOE) polymorphisms and neurodevelopmental outcome after infant cardiac surgery. Formal neurodevelopmental testing was performed at four years of age, including tests for attention, impulsivity, memory, cognition, language skills, executive function, social competence and visual-motor and fine-motor skills.

The median gestational age was 39 weeks with 125 patients born at 40 weeks or older. Older gestational age predicted better performance for short and long-term outcomes including cognition, visual-motor and fine-motor skills.

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Cryoballon-Based Technology Treats Atrial Fibrillation

Medtronic, based in Minneapolis, recently announced that its cardiac catheter system, Arctic Front, the first cryoballon-based technology treatment for a common type of irregular heartbeat, was approved by Health Canada.

Cryoballon technology uses a coolant delivered through a catheter to block atrial fibrillation, a common arrhythmia.  The minimally-invasive procedure creates circumferential lesions around the pulmonary vein, which can cause an irregular heartbeat through erratic electrical signals. The cooling technology allows the catheter to adhere to the tissue, and this leads to increased stability.

Health Canada approved the treatment based on a study demonstrating that 69.9% of patients treated with the system were free from atrial fibrillation at one year, compared to only 7.3% of patients who were free from atrial fibrillation at one year after treatment with drug therapy.

Half of all diagnosed atrial fibrillation patients fail drug therapy, according to recent research.  If atrial fibrillation is left untreated, patients have up to a five times higher risk of stroke and an increased chance of developing heart failure.

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